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Not Yet Recruiting NCT05678491

Endoscopic Treatment of Gastroesophageal Reflux Disease

Conditions: Gastro Esophageal Reflux Disease

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 12
Sponsor: St. Olavs Hospital

Location: Norway

Summary

Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus.The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are:Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal refluxDoes the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors)Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.

Eligibility Criteria

Inclusion Criteria (both criteria must be fulfilled):GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95%Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment.Exclusion Criteria:Hiatal hernia > 2 cmAge < 18_yearsPrevious esophageal or gastric surgery,Preexisting esophageal strictureAnti-coagulant medicationUse of platelet inhibitors other than acetylsalicylic acidManometric indication of motility disorderConnective tissue diseasesBMI > 30Chronic liver diseaseCoronary heart diseaseChronic obstructive pulmonary diseaseOther significant comorbidityIndication for long-term PPI use other than GERD

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05678491). StuddyBuddy aggregates publicly available trial information.